Archived - Unsafe Patient Lead Wires

Starting date:

January 14, 1994

Posting date:

January 14, 1994

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170005

• Affected products

Notice about Health Canada advisories

No. 105 January 14, 1994

To: Hospital Administrators, Directors of Paediatric and Biomedical Departments, Home Care Providing Companies and Institutions, Manufacturers and Distributors of Apnea and ECG Monitors and their Accessories

Subject: Unsafe Patient Lead Wires

Lead wires with miniature banana-plug connectors are unsafe for use with patient monitors, since the wires can be accidentally plugged into an electrical power cord or a wall outlet instead of the monitor. If this error is made, the patient as well as the care giver can be electrocuted or suffer severe burns.

On September 3, 1993, the US FDA issued a safety alert to warn US hospital administrators, risk managers and paediatric department directors about this risk. The letter was prompted by a recent incident in which a baby on an apnea monitor was electrocuted. Inappropriate lead wires were used and apparently were accidentally connected to an electrical power source.

Although the FDA safety alert concentrated on lead wire connectors used in apnea monitoring, the same potential risk exists with ECG and other patient monitors, since the same lead wire connectors are widely used.

The Health Protection Branch has confirmed that in the last 7 - 8 years all apnea monitors have been sold with patient cables and leads designed to prevent unsafe connections. Some ECG monitors have leads and cables that incorporate similar safety features. However, a number of older apnea monitors and a large number of cardiac monitors still use the unsafe miniature banana-plug connectors. If these devices are located near the newer apnea monitors, hospital staff may inadvertently switch cables and lead wires, creating a hazard.

The Health Protection Branch recommends that:

• Hospitals and home care providers immediately remove all unprotected lead wires (i.e., those with miniature banana-plug connectors) from areas where apnea monitors are used, to prevent connection of the lead wire to a power source. These unsafe lead wires should be replaced with safety protected leads;
• Hospitals implement a program to replace all unprotected lead wires with safe alternatives, in all areas where patient monitors are used. The Health Protection Branch agrees with the US FDA that the following precautions should be taken until the hospital replaces all unprotected lead wires:
  • Mark all power cords at the female end with the words "120 volts" to prevent staff from accidentally inserting an electrode lead wire;
  • Do not disconnect at the junction between the lead wire and the patient lead. Place tape over this connection to make it inconvenient to disconnect at this point;
  • Hardwire or clamp the power cable to the monitor so that the power cable is unavailable for any inappropriate connection.

Inquiries concerning this hazard and reports of similar accidents should be addressed to the Director, Medical Devices Bureau, Environmental Health Directorate, Health Protection Branch, Tunney's Pasture, Ottawa, Ontario, K1A 0L2. Telephone: (613) 952-7125, Fax: (613) 957-7318. Medical device problems may also be reported through the toll free Medical Devices Hotline at 1-800-267-9675.

Kent R. Foster
Assistant Deputy Minister

^© Minister of Supply and Services, 1994

Affected products